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TeraRecon Aorta.CT

by TeraRecon, Inc.

Ref 1

TeraRecon Aorta.CT (1) is a Class IIa device made by Terarecon Inc., registered in EUDAMED on 2 Apr 2026 (Basic UDI-DI ++B220AORTACTQP), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B220AORTACTQP Basic UDI-DI +B220AORTACT0UDI-DIDate2 Apr 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
1
Primary DI / UDI-DI
+B220AORTACT0
Basic UDI-DI
++B220AORTACTQP
Direct marketing DI
+B220AORTACT0
EMDN code
Z11030592 Radiology instruments - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000008772
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

Other properties (14, all answered No)